Complex wire formed devices

ABSTRACT

The devices and methods described herein relate to jointless construction of complex structures. Such devices have applicability in through-out the body, including clearing of blockages within body lumens, such as the vasculature, by addressing the frictional resistance on the obstruction prior to attempting to translate and/or mobilize the obstruction within the body lumen

FIELD OF THE INVENTION

The devices described herein are constructed in wire form where thewires diverge from a main bundle to form a variety of shapes that form acomposite device. The benefit of such a diverging wire construction isthat the composite complex device can be of a “joint-less” construction.Such devices have applicability in through-out the body, includingclearing of blockages within body lumens, such as the vasculature, byaddressing the frictional resistance on the obstruction prior toattempting to translate and/or mobilize the obstruction within the bodylumen.

BACKGROUND OF THE INVENTION

Many medical device applications require advancement of device in areduced profile to a remote site within the body, where on reaching atarget site, the device assumes or is deployed into a relatively largerprofile. Applications in the cerebral vasculature are one such exampleof medical procedures where a catheter advances from a remote part ofthe body (typically a leg) through the vasculature and into the cerebralregion of the vasculature to deploy a device. Accordingly, the deployeddevices must be capable of achieving a larger profile while being ableto fit within a small catheter or microcatheter. In addition, the degreeto which a physician is limited in accessing remote regions of thecerebral vasculature is directly related to the limited ability of thedevice to constrain into a reduced profile for delivery.

Treatment of ischemic stroke is one such area where a need remains todeliver a device in a reduced profile and deploy the device toultimately remove a blockage in an artery leading to the brain. Leftuntreated, the blockage causes a lack of supply of oxygen and nutrientsto the brain tissue. The brain relies on its arteries to supplyoxygenated blood from the heart and lungs. The blood returning from thebrain carries carbon dioxide and cellular waste. Blockages thatinterfere with this supply eventually cause the brain tissue to stopfunctioning. If the disruption in supply occurs for a sufficient amountof time, the continued lack of nutrients and oxygen causes irreversiblecell death (infarction). Accordingly, immediate medical treatment of anischemic stroke is critical for the recovery of a patient.

Naturally, areas outside of ischemic stroke applications can alsobenefit from devices that can assume a profile for ultimate delivery toremote regions of the body.

Regardless of the area where the device is to be used, when fabricatingsuch a device the joints between adjacent shapes or sections of thedevice often impede the ability of the device to assume a sufficientlyreduced profile or interfere with the geometry/stiffness of the devicecausing problems when navigating the device through the body. Also,joints lead to potential failure locations, and may lead to fracturedand embolized components within the body. Such joints may includewelded, glued, or otherwise separately joined pieces into one or morepoints of connection.

Accordingly, a need remains for devices that can assume deployedconfigurations and are fabricated to eliminate or reduce the number ofjoints and/or connection points in the device. Doing so allows thedevice to have a compact and smooth configuration making it easier fordelivery through a microcatheter; and leads to a safer device less proneto breaking or embolizing.

SUMMARY OF THE INVENTION

The examples discussed herein show the inventive device in a form thatis suitable to retrieve obstructions or clots within the vasculature.The term obstructions may include blood clot, plaque, cholesterol,thrombus, naturally occurring foreign bodies (i.e., a part of the bodythat is lodged within the lumen), a non-naturally occurring foreign body(i.e., a portion of a medical device or other non-naturally occurringsubstance lodged within the lumen.) However, the devices are not limitedto such applications and can apply to any number of medical applicationswhere elimination or reduction of the number of connection points isdesired.

In one variation of the devices described herein, the device comprises amain bundle or group of wires that diverge to form a device havingvarious shapes but few or no connections points or joints (wherefabrication of such a construction is referred to as “jointless”).

The term shape (or shaped section), when applied to the various shapesof the device, is intended to identify different parts of the devicewhere the wires/fibers form different sections or portions of thedevice. Each such region or shape has a structure that serves adifferent function of the device. In one example of such a device, afirst shape can be a connector portion and a second shape can be abasket or mesh shape.

In this case, the first shape (the connector portion) has a differentstructure and serves a different function than the second shape (thebasket or mesh shape). In another example, a first shape can be aconnector portion, a second shape can be a traversing section, and thethird shape can be a second connector shape. Again, each shape serves adifferent function (although in this example the first and third shapesmay have similar structures). In most variations of the device, adjacentshapes will have different structures or will be separated by the wiresthat diverge/converge to form adjacent shapes (e.g., two adjacentshapes, each forming connector shapes but are separated by wires thattraverse between the connector shapes). The different shapes may notnecessarily be spaced axially along the device; instead, as shown below,two shapes may form a single connector portion (e.g., see FIG. 6C).

In one variation, the device is adapted for delivery through a catheterand includes a main bundle comprising a group of wires having a firstend extending through the catheter and a second end, where the mainbundle of wires diverge at the second end to form a first shapedsection, the first shaped section farther comprises an expanded profileand a reduced profile for delivery through the catheter, a plurality ofindividual subsets of wires each diverging from the first shaped sectionto form a second shaped section, and where the individual subsets ofwires converge to form a third shaped section, where the third shapedsection comprises an expanded profile and a reduced profile for deliverythrough the catheter, and where the convergence and divergence of wiresoccurs without junctions between wires.

The term diverge includes uncoupling or separating of joined wires. Inaddition, a group of wires that form a first shape may all diverge toform a new composite shape. For example, a bundle of wires may form aloop shape and ultimately bend to extend in a direction substantiallynormal to the loop shape. In such a case, the wires can be considered todiverge from the loop shape to form a second shape.

The devices of the present invention typically include a main bundlefrom which the wires extend. In most case, the main bundle extends for alength sufficient to withdraw the device from a body of a patient.Accordingly, in such cases, the main bundle shall extend through thelength of a catheter. In alternate constructions, the main bundle may beaffixed to a single wire or member. In such cases, the single wire ormember is used to manipulate the device, which allows shortening of thelength of the main bundle.

Devices of the present invention can incorporate any number of wires ofdifferent characteristics including, but not limited to, materials,shapes, sizes and/or diameters. Clearly, the number of permutations ofdevice configurations is significant. Providing devices with such acomposite construction allows for the manipulation of the device'sproperties to suite the intended application.

In an additional variation, the devices can also include a basket ormesh shape structure that assists in the removal of obstructions fromthe body. In some cases, these basket structures are used as a capturingsection. Although any number of shapes is contemplated, a few examplesof such shapes include a basket, a filter, a bag, a coil, a helical wirestructure, a mesh, a single wound wire, and a plurality of crossingwires.

In some cases where the device is intended to remove obstructions fromthe vasculature, the device and catheter may be constructed to permitrelative rotation of the ends of the device such that upon rotation aportion of the device converts to a high friction surface to aid inremoving the obstruction.

As noted herein, the joint-less construction improves the flexibilityand strength of the device by eliminating joints, connection points, orother attachment points. In addition, the joint-less constructionimproves the ability of the device to be delivered through a smallmicrocatheter. As a result, the device and microcatheter are able toaccess remote regions of the vasculature.

The devices may be fabricated to be self-expanding upon deployment froma catheter. Alternatively, the devices can be constructed fromshape-memory alloys such that they automatically deploy upon reaching apre-determined transition temperature.

When used in the vasculature to retrieve obstructions, the devices mayinclude a low friction mode (such as a set of parallel wires, or wiresextending axially along the lumen or vessel) that converts to anincreased friction mode (such as a compressed set of wires acting on theobstruction or a twisted set of wires acting on the obstruction). Theincrease in friction is an increase in the friction between theobstruction and the device (as opposed to the vessel wall. In somecases, the low friction mode is a low surface area mode and the highfriction mode is a high surface area mode. When configured in the lowfriction mode, the device is better suited to engage the obstructionwithout the undesirable effect of prematurely mobilizing the obstructionor compacting the obstruction (e.g., when wires are slid across theobstruction in a transverse motion). Upon engaging the obstruction, thedevice will conform to a high friction mode with respect to theobstruction (in some cases the device will have an increased surfacearea mode). This high friction mode permits the device to better gripthe obstruction for ultimate removal of the obstruction.

The operation of the devices and method described herein secure theobstruction, overcome the elastic forces of the obstruction, and thenremove the obstruction from the anatomy without losing or fractionatingthe obstruction. In one variation of the invention, this is accomplishedby the obstruction removal device interacting with the obstruction inthe following manner: (1) a portion of the wires are delivered distal tothe obstruction by passing either through the obstruction or between theobstruction and the vascular wall; (2) the traversing wires are pulledproximally to engage a basket shaped section of the device around theobstruction, the basket shaped section engages the obstruction withoutcausing significant mobilization of the obstruction; (3) the device ispulled further proximally and the surrounding portion now mobilizes theobstruction.

As shown below, variations of the devices have a configuration thatprovides a path for a portion of the device to surround the obstruction.The paths are made using sets or subsets of wires that allow for lowfrictional translation of the device over the obstruction withoutcausing axial translation of the obstruction. This mechanism isdescribed in more detail below.

Once in the proper position, a portion of the device increases thefrictional contact with the obstruction to disperse the pulling forcemore evenly across the obstruction. The increase points of contact allowfor removal of the obstruction through tortuous anatomy while ensuringthat the obstruction will not escape the encapsulation.

It should be noted that reference to surrounding, capturing or securingthe obstruction includes partially and/or fully surrounding, engulfing,encapsulating, and/or securing the obstruction. In any case, a portionof the device engages the obstruction prior to translation of theobstruction within the lumen. As noted herein, a portion of the devicemay convert into a surrounding section (e.g., when wires reorient toincrease the friction acting on the obstruction). Accordingly, thesewires convert into a surrounding section.

It should be noted that in some variations of the invention, all or someof the device can be designed to increase their ability to adhere to theobstruction. For example, the wires may be coupled to an energy source(e.g., RF, ultrasonic, or thermal energy) to “weld” to the obstruction.Application of energy to the device can allow the surrounding portion todeform into the obstruction and “embed” within the obstruction.Alternatively, the device can impart a positive charge to theobstruction to partially liquefy the obstruction sufficiently to allowfor easier removal. In another variation, a negative charge could beapplied to further build thrombus and nest the device for better pullingforce. The wires can be made stickier by use of a hydrophilicsubstance(s), or by chemicals that would generate a chemical bond to thesurface of the obstruction. Alternatively, the filaments may reduce thetemperature of the obstruction to congeal or adhere to the obstruction.

Additional devices and methods for treating ischemic stroke arediscussed in commonly assigned U.S. patent application Ser. No.11/671,450 filed Feb. 5, 2007; Ser. No. 11/684,521 filed Mar. 9, 2007;Ser. No. 11/684,535 filed Mar. 9, 2007; Ser. No. 11/684,541 filed Mar.9, 2007; Ser. No. 11/684,546 filed Mar. 9, 2007; and Ser. No.111/684,982 filed Mar. 12, 2007; the entirety of each of which isincorporated by reference. The principles of the invention as discussedherein may be applied to the above referenced cases to produce devicesuseful in treating ischemic stroke. In other words, the wire-shapedconstruction of devices according to present invention may assume theshapes disclosed in the above-referenced cases.

BRIEF DESCRIPTION OF THE DRAWINGS

Each of the following figures diagrammatically illustrates aspects ofthe invention. Variation of the invention from the aspects shown in thefigures is contemplated.

FIG. 1A illustrates an example of a device according to the presentinvention when used in a system for removing obstructions from bodylumens.

FIG. 1B illustrates a first variation of the device having a joint-lessconstruction.

FIG. 1C illustrates another variation of a main bundle of wiresdiverging in a joint-less construction.

FIG. 2A illustrates an example of an obstruction lodged within a bodylumen.

FIGS. 2B to 2F illustrate advancement of a catheter beyond anobstruction and placement of a variation of the inventive device aroundthe obstruction.

FIGS. 2G to 2H illustrate devices according to the present inventiononce converted to a high friction mode.

FIGS. 3A to 3B illustrate additional variations of the inventive devicehaving a basket or mesh structure formed from diverging wires.

FIGS. 3C to 3D show positioning a variation of a device distally to anobstruction to ultimately translate a basket shaped section over theobstruction.

FIGS. 4A to 4B illustrate another variation of a portion a deviceconfigured to convert from a low friction mode to a high friction mode.

FIG. 5 illustrates an example of manufacturing a device by orienting thewires on a planar fixture.

FIGS. 6A to 6D illustrate variations of the shaped sections that can beformed from the wires forming the device.

FIG. 6E illustrates hooks, fibers, and/or barbs for increasing theability of the device to remove obstructions.

FIGS. 7A to 7C illustrate additional variations of shapes for use in thedevices according to the present invention.

FIGS. 8A to 8G also illustrate additional variations of obstructionremoval devices, focusing mainly on variations of the surroundingportion.

FIGS. 9A to 9C show another variation of a medical device havingmultiple bundles of wires where the wires diverge to form capturingsections.

DETAILED DESCRIPTION

It is understood that the examples below discuss uses in the cerebralvasculature (namely the arteries). However, unless specifically noted,variations of the device and method are not limited to use in thecerebral vasculature. Instead, the invention may have applicability invarious parts of the body. Moreover, the invention may be used invarious procedures where the benefits of the method and/or device aredesired.

FIG. 1A illustrates a system 10 for removing obstructions from bodylumens as described herein. In the illustrated example, this variationof the system 10 is suited for removal of an obstruction in the cerebralvasculature. Typically, the system 10 includes a catheter 12microcatheter, sheath, guide-catheter, or simple tube/sheathconfiguration for delivery of the obstruction removal device to thetarget anatomy. The catheter should be sufficient to deliver the deviceas discussed below. The catheter 12 may optionally include an inflatableballoon 18 for temporarily blocking blood flow or for expanding thevessel to release the obstruction.

It is noted that any number of catheters or microcatheters maybe used tolocate the catheter/microcatheter 12 carrying the obstruction removaldevice (not illustrated) at the desired target site. Such techniques arewell understood standard interventional catheterization techniques.Furthermore, the catheter 12 may be coupled to auxiliary or supportcomponents 14, 16 (e.g., energy controllers, power supplies, actuatorsfor movement of the device(s), vacuum sources, inflation sources,sources for therapeutic substances, pressure monitoring, flowmonitoring, various bio-chemical sensors, bio-chemical substance, etc.)Again, such components are within the scope of the system 10 describedherein.

In addition, devices of the present invention may be packaged in kitsincluding the components discussed above along with guiding catheters,various devices that assist in the stabilization or removal of theobstruction (e.g., proximal-assist devices that holds the proximal endof the obstruction in place preventing it from straying during removalor assisting in the removal of the obstruction), balloon-tipped guidecatheters, dilators, etc.

FIG. 1B illustrates a first variation of a device according to thefeatures described herein. As shown, the device 200 generally includes amain bundle 202 comprising a group of individual wires 204. Theindividual wires 204 may be comprised of a number of different wires, ora single type of wire. Variations of the wires 204 are discussed indetail below; however, the wires 204 can be strands, filaments, or anysimilar structure that is able to be joined to form the device. Thebundle 106 may be braided, wrapped, twisted, or joined in any mannersuch that they do not separate or become unbundled except where desired.As shown, the main bundle 202 diverges to form a first shaped section206. In this particular example, the bundle 202 diverges in two sections208, 210 which then diverge again to form the first shape 206.

Next, the wires 204 forming the first shape 206 diverge in groups orsubsets of wires 212, 214, 216, 218, to form a second shaped section220. Ultimately, the subsets of wires 212, 214, 216, 218 converge toform a third shaped section 224. The ends of the wires 204 may terminatein the final shape of the device. In other variations, the device isconstructed such that the shapes formed by the divergence andconvergence of the wires are formed by the center of the individualwires where all the ends of the wires are located in the main bundle202. In such a configuration, the device will not contain anyterminating ends. In such a case, the wires forming the shapes arecontinuous and the device is completely joint or connection free.

In the illustrated variation, the first shaped section and third shapedsection 206, 224 form loop shapes while the second shaped section formsa series of traversing elements that extend between the loops. Whenformed into traversing elements, the wires extend substantially parallelto one another and normal to the shaped sections so that they can spanbetween the first and third shaped sections.

As noted below, any number of shapes may be formed with this joint-lessconstruction. In addition, the devices described herein may have anynumber of shaped sections. For example, in the illustrated variation,the first and second 206, 224 shaped sections form two loop typestructures. However, the device may be constructed such that the wiresdiverge to form any number of looped shaped structures.

In any case, the individual wires 204 form a composite device 200 havingindividual sections that can serve various functions upon deployment ofthe device 200. The divergence and convergence of the wires minimizesthe numbers of joints or connections that would otherwise be required toform the composite shape. Such a configuration produces a smoothgeometry given that the wires forming the device 200 are continuous.

FIG. 1C illustrates a partial view of another variation of a device 200according to the present invention. In this variation, the device 200comprises a main bundle 202 where the main bundle 202 diverges to formthe first shape 206. In contrast with the device shown in FIG. 1B, themain bundle 206 does not diverge to form sections 208, 210 prior toforming the first shape 206.

It is noted that any number of shapes, configurations, as well as anynumber of joined wires may be contemplated to form devices under thepresent disclosure. However, variations of the invention includeselecting a number of wires 204 to produce specific structuralproperties to the device. For example, if it is desired that each subset212, 214, 216, 218, have at least two wires, then naturally the firstsection, third section, and main bundle 202 must have at least twowires. However, in some cases, it may be desired that these sectionshave additional wires to impart the required characteristics. Forexample, in the illustrated variation, the main bundle may comprise anynumber of wires that do not diverge to form subsequent shapes in thedevice. In other words, not all of the wires forming a section arerequired to diverge to form an adjacent section. Instead, thesenon-diverging wires may simply “loop” back away from the device. In anadditional variation, one or more wires may diverge to form a firstshape and part of a second shape. Then the wires can loop back toconverge again with the main bundle.

Of course, the opposite construction is also within the scope of thisdisclosure. Namely, that each wire from the main bundle diverges to forman adjacent section or shape.

FIGS. 2A to 2F show one example of the deployment of a basic structureof a device according to the present invention about an obstruction in avessel. The figures are intended to demonstrate the initial placement ofthe device immediately prior to removal of the obstruction either usinga filter or by torquing, rotating and/or twisting the device endsrelative to one another. This action converts the device from a lowfriction device to a high friction device (where the low/high frictionis the friction between the device and the obstruction). This action mayalso be referred to as a low surface area mode converting to a highsurface area mode (in cases where the device extends beyond theobstruction and relative motion between ends of the device causes thedevice to shrink in axial length as it is twisted.)

FIG. 2A illustrates an example of an obstruction 2 lodged within a bodylumen or vessel 6. In the case where the vessel is a cerebral artery,the obstruction may result in an ischemic stroke. Using standardinterventional catheterization techniques, a microcatheter 102 andguidewire 104 traverse the obstruction. The microcatheter 102 may beadvanced through the obstruction 2. Alternatively, the microcatheter 102may “push” aside the obstruction and is advanced around the obstruction.In any case, the microcatheter 102 travels from the near end 3 (orproximal side) of the obstruction 2 to the far end 4 (or distal side) ofthe obstruction 2. It is noted that the catheter 102 may be centered oroff-center with respect to the obstruction 2. Furthermore, the devicemay or may not be used with a guidewire to navigate to the site andtraverse the obstruction.

FIG. 2B shows another variation where a microcatheter 102 traverses theobstruction 2 between the wall of the vessel 6 and the obstruction 2. Asshown, the open end of the microcatheter 102 is distal to theobstruction 2 and is now positioned to deploy devices for removal of theobstruction 2. This variation shows the device after removal of anyguidewire. However, some variations of the device may be placed withoutan accompanying guidewire. Moreover, the structures discussed herein maybe directly incorporated into a guidewire assembly where deployment mayrequire a sheath or other covering to release the components fromconstraint.

FIG. 2C illustrates deployment of a portion of the device 200 fromwithin the microcatheter 102 distal to the obstruction 2. In thisexample, the third shaped section 224 deploys distally to theobstruction 2. As noted herein, depending on the properties of thedevice 200 as determined by the types of wires used, third shapedsection 224 can be self-expanding such that it assumes, or movestowards, the expanded profile (as shown) upon deployment from theconstraint of the microcatheter 102. Alternatively, the third-shapedsection 224 can be actuated to assume the shape (e.g., upon reaching atransition temperature where one or more wires comprise a shape memoryalloy).

FIG. 2D shows withdrawal of the microcatheter 102 to the proximal side 3of the obstruction 2. The spacing between the third shaped section 224and the obstruction 2 may vary. In some cases, the third shaped section224 will move closer towards the obstruction 2 during spacing of theremainder of the device as discussed below. The third shaped section 224remains in place either using the inherent friction of the wires againstthe vessels and/or obstruction 2. Alternatively, or in combination, awire-type member (not shown) may provide an opposing force against thethird shaped section 224 as the catheter 102 moves proximal to theobstruction 2.

As noted above, this variation of the device 200 include a plurality ofsubsets 212, 214, 216, 218 that traverse between the first and thirdshaped sections 206, 224. As shown in FIG. 2E, eventually, second shapedsection 220 spans across the obstruction 2 as shown.

FIG. 2F illustrates the device 200 after the second shaped section 220separate about the obstruction 2 This action causes the second shapedsection 220 to span the obstruction 2 while reorienting towards anexterior of the obstruction 2. The subsets of wires may remain partiallyor fully within the obstruction 2. However, given that the filaments arespaced about the loops formed by the first shaped section 206 and thirdshaped section 224, the filaments shall separate radially over theobstruction allowing for the subsequent ensnaring and removal of theobstruction 2.

Spacing the subsets that traverse across the obstruction can occur via anumber of modes such as tensioning, expanding, spreading separatingand/or withdrawing the wires. Regardless of the mode used, the subsetsare intended to be positioned at or near a surface of the obstruction sothat they can reduce the effects of any friction between the obstructionand the lumen or vessel wall.

FIGS. 2G to 2H illustrates examples of the device 200 that ensnare theobstruction 2 after the device is in the configuration demonstrated byabove. In these cases, the devices 200 transform from a low frictionmode to a higher friction mode for removal of the obstruction 2. FIGS.2G to 2H illustrate rotation of the ends of the device 206 and 224relative to one another. The resulting action converts the device 200 toa high friction mode to ensnare the obstruction 2 within the traversingsection formed by the wires in the second shaped section 220. As notedherein, either connector may rotate while another connector remainsstationary. Alternatively, each connector may rotate with the rate ofrotation for one connector being slower than another. In yet anothervariation, each connector may be rotated in opposite directions.

Although the variation shows only four individual subsets of wirestraversing across between the first and third shaped sections 206 and224 any number subsets may be used so long as the rotation converts thewires into a relatively increased friction mode as compared to the lowfriction mode (when the subsets are in a parallel configuration). Thelow friction mode is represented by FIG. 2F. FIG. 2G illustrates adevice in a high friction mode where the subsets of wires forming thesecond shaped section 220 twist and cross one another over the length ofthe obstruction 2. It should be noted that additional shaped sections206, 220, and/or 224 may be required to produce the crossing patternshown in FIG. 2G, or other preferred patterns when the device is twistedto convert to a high friction mode.

In contrast, the device 200 may be configured to transform as shown inFIG. 2H. In this case, conversion of the device 200 causes twisting atpoints 116 where the twist points 116 are proximal and distal to theobstruction 2. To accomplish this, the device 200 can be selected tohave a length greater than the targeted obstruction 2. Upon rotation,the second shaped section 220 formed from the subsets of wires thattraverse across obstruction remain uncrossed over the length of theobstruction 2. In some cases, the second shaped section 220 canexperience some twisting and will not remain parallel. The relativemotion of the ends 206 and 224 as well as the twist points 116 causesthe second shaped section 220 to exert a compressive force on theobstruction 2 without crossing one another over the length of theobstruction. Accordingly, while the surface area in contact between thesecond shaped section 220 and obstruction 2 remains relatively the same,the compressive action of the second shaped section 220 onto theobstruction converts the device 200 to a high friction mode on theobstruction.

The rotation of the ends of the device 206, 224 can be performed in anynumber of ways as known to those skilled in the art. In either case, theobstruction 2 becomes ensnared (and/or encapsulated) and can be removedfrom the body.

FIG. 3A illustrates another variation of a device where the wires 204diverge from-an end of the device 200 to form a basket 226 shape orstructure. The basket structure 226 may also be referred to as a filteror surrounding portion. In variations of the device, the basket 226 issufficiently permeable to allow blood flow therethrough. As noted above,basket 226 may be any structure that covers, encapsulates, engulfs,and/or ensnares the obstruction either fully or partially. Accordingly,although the basket 226 is illustrated as a filter/bag, the wires maydiverge to form a coil, helical shape, other mesh structure, or anyother structure that may translate or remove the obstruction 2 once thefrictional component is addressed.

FIG. 3B shows a top view of a variation of a device 200 showing anotherconfiguration of a basket shape 226 formed by wires that diverge from anend of the device 200. In this variation, the wires 204 diverge insubsets 228 from the third shaped section 224. However, the subsets 228continue to diverge at the far end of the device to form a mesh region230 (i.e., an area of dense wire coverage). This mesh region 230 canincrease the contact area between the wires 204 and the obstruction,which assists in removal of the obstruction. Divergence of wires couldoccur multiple times as wires head to the distal region of basket,creating a basket with denser and denser coverage moving distally.

FIG. 3C depicts a variation of the device similar to that of FIG. 3A. Asshown, the device 200 is deployed distally to the obstruction 2As shown,this deployment allows the subsets of wires that extend along the device200 to expand within the vessel 6 prior to contacting the occlusion 2.

Next, as shown in FIG. 3D, the device 200 is pulled over the occlusion2. As noted herein, the subsets of wires that form the second shapedportion 220 addresses the frictional forces that act between theobstruction and the vessel wall. Conventional devices that provide a bagattached to a wire (such as a vascular filter or distal protectiondevice), are typically unable to remove the obstruction because theycannot overcome these frictional forces that lodge the clot against thevessel wall. Typically, such conventional devices are only designed to“catch” free floating clots. Providing low friction with respect to theclot and the vessel allows for positioning of the device withoutdisrupting or further compacting the clot against the vessel wall. Oncethe wires of the device surround or are spaced about the obstruction,they reduce the friction between the clot and vessel wall by reducingpoints of contact. Once these wires surround the clot, they permittranslation of the device to permit a basket shaped section 226 tosurround the obstruction for removal. Eventually, the device 200 ispulled so that the basket shaped section 226 captures the obstruction 2allowing it to be removed.

FIG. 4A illustrates a variation of a device 200 where the first shapedsection is a loop shaped member 206 and the third shaped section 224forms a closed end where the wires converge. As shown, subsets 212, 214,216, 218 diverge from the first shaped section 206 and extendsubstantially parallel to the loop. Rather than converging to formanother loop, the subsets converge to form a shaped section 224 having aclosed end configuration. FIG. 4B illustrates the variation of FIG. 4Aafter it converts to a high friction mode over the obstruction 2 viarotation of the first shaped section 206. As with other variations, thenumber of subsets may vary as needed. In addition, the subsets of wires212, 214, 216, 218 can further diverge to form a denser mesh pattern ator towards the third shaped section 224.

As shown, rotation of the shaped section 206 forms a twist point 116proximal to the obstruction 2. In some cases, the subsets of wires 212,214, 216, 218 can experience some twisting and may not remain parallel.The rotation of the shaped section 206 as well as the twist point 116causes the subsets of wires 212, 214, 216, 218 to exert a compressiveforce on the obstruction 2 without crossing one another over the lengthof the obstruction. Accordingly, while the surface area in contactbetween the subsets of wires 212, 214, 216, 218 and obstruction 2remains relatively the same, the compressive action of the subsets ofwires onto the obstruction converts the device 200 to a high frictionmode on the obstruction.

FIG. 5 shows one example of a method for constructing devices accordingto the present invention. A main bundle of wires 202 is brought into afixture (not shown). The fixture permits routing of the wires in thepattern as shown. In this particular variation, the main bundlecomprises 8 wires. However, number of wires is intended for exemplarypurposes only. Clearly, any number of wires may be used. As shown thewires diverge in the region marked 232 to form four separate subsets ofwires 212, 214, 216, 218. Again, in this example, each subset of wirecomprises 2 individual wires. This configuration is for illustrativepurposes as the number of wires in each subset is not required to be thesame for all.

Next, the wires converge in the region marked as 234. It is noted thatif the device is constructed on a planar fixture, the wires (onceoriented) will be wrapped around a cylindrical structure and heat set toimpart the shapes shown above. Accordingly, the regions marked by 232and 234 assume partial loop shapes as the planar wire assembly iswrapped around the cylindrical fixture. In alternate variations, thewires may be oriented on a cylindrical fixture and heat set into a finalshape. Doing so obviously eliminates the need to wrap the planar wireassembly about a cylindrical structure.

As shown, once the wires form the region marked as 234, they divergeonce again to form a basket shaped section or filter 226 as discussedabove. Accordingly, upon wrapping the device wires, the region marked as234 assumes a loop shaped section. The wires forming the basket shapedsection or filter 226 can either terminate at the end of the basket orfilter 226. Alternatively, the wires can be looped around such that theyeventually extend back through the main bundle 202 or loop back and andterminate in any portion of the device.

The above described wire form construction allows for a number ofconfigurations depending on the particular application. For example, theindividual wires 204 may themselves comprise a bundle of smaller wiresor filaments. In addition, the wires can be selected from materials suchas stainless steel, titanium, platinum, gold, iridium, tantalum,nitinol, and/or polymeric strands. In addition, the wires used in adevice may comprise a heterogeneous structure by using combinations ofwires of different materials to produce a device having the particulardesired properties. For example, one or more wires in the device maycomprise a shape memory or superelastic alloy to impart predeterminedshapes or resiliency to the device. In some variations, the mechanicalproperties of select wires can be altered. In such a case, the selectwires can be treated to alter properties including: brittleness,ductility, elasticity, hardness, malleability, plasticity, strength, andtoughness.

In addition, the device may include a number of radiopaque wires, suchas gold and platinum for improved visibility under fluoroscopic imaging.In other words, any combination of materials may be incorporated intothe device. In addition to the materials, the size of the wires may varyas needed. For example, the diameters of the wires may be the same ormay vary as needed.

In addition, the individual wires may have cross-sectional shapesranging from circular, oval, d-shaped, rectangular shape, etc. Moreover,the device is not limited to having wires having the samecross-sectional shape. Instead, the device can have wires havingdifferent cross-sectional shapes. To illustrate one such example, adevice can have 8-12 wires made of 0.003″ round superelastic material(e.g., nitinol). The device may additionally have 2-4 wires made from0.002″ platinum for fluoroscopy. Of the 8-12 nitinol wires, 1-4 of thesewires can be made of a larger diameter or different cross-section toincrease the overall strength of the device. Finally, a couple ofpolymer fibers can be added where the fibers have a desired surfaceproperty for clot adherence, etc. Such a combination of wires provides acomposite device with properties not conventionally possible in view ofother formation means (such as laser cutting or etching the shape from atube or joining materials with welds, etc.). Clearly, any number ofpermutations is possible given the principles of the invention.

In another example, the device may be fabricated from wires formed froma polymeric material or composite blend of polymeric materials. Thepolymeric composite can be selected such that it is very floppy until itis exposed to either the body fluids and or some other deliveredactivator that causes the polymer to further polymerize or stiffen forstrength. Various coatings could protect the polymer from furtherpolymerizing before the device is properly placed. The coatings couldprovide a specific duration for placement (e.g., 5 minutes) after whichthe covering degrades or is activated with an agent (that doesn't affectthe surrounding tissues) allowing the device to increase in stiffness sothat it doesn't stretch as the thrombus is pulled out. For example,shape memory polymers would allow the device to increase in stiffness.

As discussed herein, the shaped section connectors may be otherstructures than loops. Moreover, variations of the invention includeconnectors that may be drawn down to a smaller size to facilitateremoval from the body after securing the obstruction. This may beaccomplished by torquing the device or part thereof, by re-sheathingpart or all of the device or by any mechanical means designed into thefeatures of the device itself. Any of these actions, or combinationthereof, may also serve to compress or decrease the diameter of theobstruction itself to facilitate removal from the body.

As with the above examples, the illustrated variation shown above, theshaped portions are formed in a loop or partial loop shape. However, asdescribed herein, the connectors may also comprise various alternateshapes (e.g., a circle, an arcuate shape, a partial circular shape, aloop, an oval, a square, a rectangle, a polygon, an overlapping loop, apair of semi-circles, a flower shape, and a FIG. 8, other shapes, etc.)FIGS. 6A to 6D illustrate some possible shapes for use in the device.The various shapes may be heat set to be either self expanding (i.e.,superelastic) or the use of shape memory alloys can allow for the deviceto assume the particular shape upon reaching a desired transitiontemperature. In certain cases, such as where the shape is an overlappingloop, a pair of semi-circles, a flower shape, a FIG. 8, or othercomplex/discontinuous shape, such a shape may be formed by a singlebundle or by one or more separate portions of wire that diverge from themain bundle.

FIG. 6A illustrates a main bundle of wires 202 that diverge in threearcuate shaped portions 242, 244, 246. Naturally, the device may havemore or less arcuate shaped sections. In this illustration, the segmentsforming the arcuate 242, 244, 246 shaped portions may simply bend toform segments that traverse across the device (as shown above.) However,such traversing sections are omitted to illustrate the arcuate shape.

FIG. 6B illustrates a main bundle 202 that ultimately diverges to forman overlapping loop shape 248. As shown, the ends of the overlappingloop may then proceed to form the traversing subsets 212, 214 discussedabove. In addition, additional subsets of wires may diverge from alocation other than the end of the overlapping loop shape 248.

FIG. 6C illustrates a main bundle that diverges to form twosemi-circular or partial circular shapes 250, 252. In this variation,the two shapes are located along the same axial section of the devicebut the shapes are separate. Again, the ends of the partial circularshapes 250, 252 may diverge to form the traversing section of thedevice. Alternatively, the traversing wires can come from otherlocations.

FIG. 6D illustrates a main bundle 202 that diverges to form a “figure-8”shape. As with other variations, additional subsets (not shown) of wiresmay diverge from the “figure-8” shape to form the traversing subsets. Inaddition, flower shaped sections may be formed by the use of additionalcircular shapes that form the petals of the flower shape or via the useof multiple “figure-8” shapes.

The exemplary shapes discussed above permit the shaped section to adjustin diameter in response to placement in varying diameters of bodylumens. It is noted that a device may have different shaped sections ondifferent ends of the device.

While many different shapes are contemplated to be within the scope ofthis disclosure, the shapes will depend upon the ultimate application ofthe device. As noted herein, the illustrated examples have particularapplicability in retrieving obstructions from the vasculature.Accordingly, for these applications the shaped sections should form ashape so that they can expand against a vessel wall without causingtrauma to the vessel. For example, upon release from the catheter, theshaped section can assume their resting shape and expand within thevessel. The resting shape can be constructed to have a size slightlygreater than that of the vessel. Sizing the device relative to thetarget vessel may assist in placing the parts of the device against avessel.

In an additional aspect, the shaped sections may be designed to have anunconstrained shape that is larger than the intended target vessel orsimply different than a cross sectional profile of the intended vessel(i.e., not circular or tubular, but e.g., linear or other differentshape). In such an example, as the shaped section is released from thedelivery catheter, the shape section attempts to return to theunconstrained shape. In those variations where the unconstrained shapeis different from the circular profile of the vessel, the leading wireassumes a shape that accommodates the vessel but is more rigid andstable since its unconstrained shape is entirely different from that ofthe vessel. In other words, the shaped section continually exerts anoutward force on the vessel.

In yet another aspect, the shaped sections shown herein may notnecessarily lie in the same plane. Instead, they can be axially spacedby an offset. One benefit of constructing the device to have non-planarshaped section is that the configuration might allow for delivery of thedevice delivered via a smaller microcatheter because the shaped sectionsdo not interfere with one another when collapsed to fit within themicrocatheter.

Another aspect applicable to all variations of the devices is toconfigure the devices (whether the traversing filament or thesurrounding portion) for better adherence to the obstruction. One suchmode includes the use of coatings that bond to certain clots (or othermaterials causing the obstruction.) For example, the wires may be coatedwith a hydrogel or adhesive that bonds to a thrombus. Accordingly, asthe device secures about a clot, the combination of the additive and themechanical structure of the device may improve the effectiveness of thedevice in removing the obstruction.

Such improvements may also be mechanical or structural. For example, asshown in FIG. 6E, the traversing members may have hooks, fibers, orbarbs 154 that grip into the obstruction when the device converts to ahigh friction mode. The hooks, fibers, or barbs 154 incorporated intoany portion of the device. However, it will be important that suchfeatures do not hinder the ability of the practitioner to remove thedevice from the body.

In addition to additives, the device can be coupled to an RF or otherpower source (such as 14 or 16 in FIG. 1), to allow current, ultrasoundor RF energy to transmit through the device and induce clotting or causeadditional coagulation of a clot or other the obstruction.

The methods described herein may also include treating the obstructionprior to attempting to remove the obstruction. Such a treatment caninclude applying a chemical or pharmaceutical agent with the goal ofmaking the occlusion shrink or to make it more rigid for easier removal.Such agents include, but are not limited to chemotherapy drugs, orsolutions, a mild formalin, or aldehyde solution.

Although not illustrated, the devices and methods described herein mayalso be useful in removing obstructions lodged within bifurcations inthe anatomy. Generally, bifurcations greatly increase the frictionalforces on the obstructions since the obstruction tends to be lodged inboth branching sections of the bifurcation. In such cases, the use ofthe presently described devices and methods may also include anadditional “puller” device that advances beyond the portion of theobstruction partially located in the bifurcated vessel.

As for other details of the present invention, materials andmanufacturing techniques may be employed as within the level of thosewith skill in the relevant art. The same may hold true with respect tomethod-based aspects of the invention in terms of additional acts thatare commonly or logically employed. In addition, though the inventionhas been described in reference to several examples, optionallyincorporating various features, the invention is not to be limited tothat which is described or indicated as contemplated with respect toeach variation of the invention.

FIGS. 7A to 7C illustrate additional variations of obstruction removaldevices. In these variations, the wires may diverge from the main wirebundle 202 to form any number of shapes and structures and specificallynot form loop or the shaped sections discussed above. For example, inFIGS. 7A to 7B the wires diverge to ultimately form a basket or filtershape 226.

FIGS. 8A to 8F illustrate various additional configurations forconstruction of join-less devices 200. As shown, the main bundle ofwires 202 diverges so that one or more wires forms the illustratedshapes.

FIGS. 9A to 9C show another variation of a medical device according tothe principles of the invention. As shown, the device 200 comprises afirst and second main bundles 202, where the main bundles comprise aplurality of wires. The devices further include a first shape and secondshapes 206 formed by a divergence of the plurality of wires into aplurality of individual first subsets of wires. In these variations, thewires diverge to form a network of individual single wires as shown inregion 226. The shapes form a three dimensional structure that is usefulfor removal of obstruction from within the body. In FIG. 9B, each shapecomprises a structure that forms a portion of the basket where a networkof wires forms an end of the basket. In FIGS. 9A and 9C the network ofwires forms the entire basket.

As noted above, the shapes 206 may range from a circle, an arcuateshape, a partial circular shape, a loop, an oval, a square, a rectangle,a polygon, an overlapping loop, a pair of semi-circles, a flower shape,and a FIG. 8 (as shown above).

Various changes may be made to the invention described and equivalents(whether recited herein or not included for the sake of some brevity)may be substituted without departing from the true spirit and scope ofthe invention. Also, any optional feature of the inventive variationsmay be set forth and claimed independently, or in combination with anyone or more of the features described herein. Accordingly, the inventioncontemplates combinations of various aspects of the embodiments orcombinations of the embodiments themselves, where possible. Reference toa singular item, includes the possibility that there are plural of thesame items present. More specifically, as used herein and in theappended claims, the singular forms “a,” “and,” “said,” and “the”include plural references unless the context clearly dictates otherwise.

1. A medical device for delivery through a catheter, the medical devicecomprising: a main bundle comprising a group of wires having a first endextending through the catheter and a second end; where the main bundleof wires diverge at the second end to form a first shaped section, thefirst shaped section farther comprises an expanded profile and a reducedprofile for delivery through the catheter; a plurality of individualsubsets of wires each diverging from the first shaped section to form asecond shaped section; where the individual subsets of wires converge toform a third shaped section, where the third shaped section comprises anexpanded profile and a reduced profile for delivery through thecatheter; and where the convergence and divergence of wires occurswithout junctions between wires.
 2. The medical device of claim 1, wherethe main bundle diverges at the second end in at least two portionsbefore forming the first shaped section.
 3. The medical device of claim1, where the main bundle extends for a length sufficient to withdraw thedevice from a body of a patient.
 4. The medical device of claim 1, wherethe main bundle of wires includes at least a first wire and a secondwire where the first and second wire each have differentcharacteristics.
 5. The medical device of claim 4, where thecharacteristics are selected from a group consisting of material,cross-sectional shape, and cross-sectional size.
 6. The medical deviceof claim 4, where the characteristics are selected from a groupconsisting of brittleness, ductility, elasticity, hardness,malleability, plasticity, strength, and toughness.
 7. The medical deviceof claim 1, where the main bundle of wires includes at least one shapememory alloy wire.
 8. The medical device of claim 1, where the mainbundle of wires includes at least one super-elastic wire.
 9. The medicaldevice of claim 1, where the main bundle of wires includes at least onepolymeric wire.
 10. The medical device of claim 1, where the main bundleof wires includes at least one wire comprising a metal alloy.
 11. Themedical device of claim 10, where the metal alloy comprises an alloyselected from the group consisting of stainless steel, titanium,platinum and gold, iridium, tantalum, nitinol, and combinations thereof.12. The medical device of claim 1, further comprising at least oneradiopaque material located on the first shaped section and/or thesecond shaped section.
 13. The medical device of claim 1, where thefirst shaped section comprises a shape selected from a circle, anarcuate shape, a partial circular shape, a loop, an oval, a square, arectangle, a polygon, an overlapping loop, a pair of semi-circles, aflower shape, and a FIG.
 8. 14. The medical device of claim 13, wherethe first shaped section is non-planar.
 15. The medical device of claim1, where the third shaped section comprises a shape selected from acircle, an arcuate shape, a partial circular shape, a loop, an oval, asquare, a rectangle, a polygon, an overlapping loop, a pair ofsemi-circles, a flower, shape, and a FIG.
 8. 16. The medical device ofclaim 15, where the third shaped section is non-planar.
 17. The medicaldevice of claim 1, where the individual subsets of wires in the secondshaped section extend substantially normal to the first shaped section.18. The medical device of claim 1, further comprising a capturingsection formed by at least one wire diverging from the third shapedsection.
 19. The medical device of claim 18, where the capturing sectioncomprises a shape selected from the group consisting of a basket, afilter, a bag, a coil, a helical wire structure, a mesh, a single woundwire, and a plurality of crossing wires.
 20. The medical device of claim1, where the individual subsets of wires each comprise a single wire.21. The medical device of claim 1, where the individual subsets of wireseach comprise a bundle of smaller wires.
 22. The medical device of claim1, where the wires have a cross-sectional shape selected from the groupconsisting of a circle, an oval, a: rectangular shape, and a D-shape.23. The medical device of claim 1, where the plurality of wires in themain bundle are braided.
 24. The medical device of claim 1, where theplurality of wires in the main bundle are wound.
 25. The medical deviceof claim 1, where the first shape section is rotatable relative to thethird shape section, such that upon rotation the second shape forms amesh or helical structure.
 26. The medical device of claim 1, where atleast one of the wires diverging from the main bundle returns to themain bundle after forming at least one of the shaped sections in thedevice.
 27. The medical device of claim 1, where each of the wiresdiverging from the main bundle returns to the main bundle after formingat least one of the shaped sections in the device.
 28. The medicaldevice of claim 1, where the first shaped section and third shapedsections forms a connector shapes and the second shaped section forms atraversing section.
 29. The medical device of claim 1, where each shapedsection is jointless.
 30. The medical device of claim 1, where eachtransition between each shaped section is jointless.
 31. Anintravascular apparatus for deployment in a vessel comprising: aplurality of wires grouped into a main bundle, where at least a firstportion of the plurality of wires diverge from the main bundle to form afirst shape; a plurality of subsets of wires diverging from the firstshape and extending normally from the first shape; a second shape formedby the convergence of the plurality of subsets of wires; where the firstshape has a first expanded profile when unconstrained, such that ondeployment in the vessel the first shape expands towards the firstexpanded profile; where the second shape is collapsible to fit withinthe microcatheter and has a second expanded profile when unconstrained,such that on deployment in the vessel the second shape expands towardsthe second expanded profile; and where the plurality of subsets of wiresextending between the first and second shapes, and are spaced apart suchthat spacing the first and second shapes causes the plurality of subsetsto move towards a wall of the vessel.
 32. The intravascular apparatus ofclaim 31, where a second portion of the main bundle diverges from themain bundle separately from the first portion to form the first shape.33. The intravascular apparatus of claim 31, where a second portion ofthe main bundle diverges from the main bundle separately from the firstportion to form a third shape.
 34. The intravascular apparatus of claim31, where each shaped section is jointless.
 35. The intravascularapparatus of claim 31, where each transition between each shape isjointless.
 36. The intravascular apparatus of claim 31, where the firstshape comprises a shape selected from the group consisting of a circle,an arcuate shape, a partial circular shape, a loop, an oval, a square, arectangle, a polygon, an overlapping loop, a pair of semi-circles, aflower shape, and a FIG.
 8. 37. The intravascular apparatus of claim 31,where the first shape is non-planar.
 38. The intravascular apparatus ofclaim 3 1, where the second shape is non-planar.
 39. The intravascularapparatus of claim 3 1, where the second shape comprises a shapeselected from the group consisting of a circle, an arcuate shape, apartial circular shape, a loop, an oval, a square, a rectangle, apolygon, an overlapping loop, a pair of semi-circles, a flower shape,and a figure
 8. 40. The intravascular apparatus of claim 31, where thesecond shape comprises a shape selected from a group consisting of abasket, a filter, a bag, a coil, a helical wire structure, a mesh, abraided wire, and a plurality of crossing wires.
 41. The intravascularapparatus of claim 31, further comprising a capturing section formed byat least one wire diverging from the second shaped section.
 42. Theintravascular apparatus of claim 41, where the capturing sectioncomprises a shape selected from the group consisting of a basket, afilter, a bag, a coil, a helical wire structure, a mesh, a single woundwire, and a plurality of crossing wires.
 43. The intravascular apparatusof claim 31, where the main bundle extends for a length sufficient towithdraw the device from a body of a patient.
 44. The intravascularapparatus of claim 31, where the plurality of wires includes at least afirst wire and a second wire where the first and second wire each hasdifferent characteristics.
 45. The intravascular apparatus of claim 44,where the characteristics are selected from a group consisting ofmaterial, cross-sectional shape, and cross-sectional size
 46. Theintravascular apparatus of claim 44, where the characteristics areselected from a group consisting of brittleness, ductility, elasticity,hardness, malleability, plasticity, strength, and toughness.
 47. Theintravascular apparatus of claim 31, where the group of wires includesat least one shape memory alloy wire.
 48. The intravascular apparatus ofclaim 31, where the group of wires includes at least one super-elasticwire.
 49. The intravascular apparatus of claim 31, where the group ofwires includes at least one polymeric wire.
 50. The intravascularapparatus of claim 31, where the group of wires includes at least onewire comprising a metal alloy.
 51. The intravascular apparatus of claim50, where the metal alloy comprises an alloy selected from the groupconsisting of stainless steel, titanium, platinum, gold, iridium,tantalum, and nitinol.
 52. The intravascular apparatus of claim 31,further comprising at least one radiopaque material located on the firstshaped section and/or the second shaped section.
 53. The intravascularapparatus of claim 31, where at least one wire comprises a shapeselected from the group consisting of a circle, an oval, a rectangularshape, and a D-shape.
 54. The intravascular apparatus of claim 31, wherethe plurality of wires in the main bundle are braided.
 55. Theintravascular apparatus of claim 31, where the plurality of wires in themain bundle are wound.
 56. The intravascular apparatus of claim 31,where the first shape is rotatable relative to the second shape, suchthat upon rotation the subsets of wires form a mesh or helical pattern.57. The intravascular apparatus of claim 31, where at least one of thewires diverging from the main bundle returns to the main bundle afterforming at least one of the shapes in the device.
 58. The intravascularapparatus of claim 31, where each of the wires diverging from the mainbundle returns to the main bundle after forming at least one of theshapes in the device. 59-93. (canceled)